Health
Alzheimer's drug embrace slows down as US doctors' reluctance grows
Nine months into the U.S. launch of the first drug proven to slow the advance of Alzheimer’s, Eisai and Biogen’s Leqembi is facing an unexpected hurdle to widespread use: an entrenched belief among some doctors that treating the memory-robbing disease is futile.
Alzheimer’s experts had anticipated bottlenecks due to Leqembi’s requirements, which include additional diagnostic tests, twice-monthly infusions and regular brain scans to guard against potentially lethal side effects.
And those issues have played a role in slow adoption since the drug was approved by the U.S. Food and Drug Administration, according to interviews with 20 neurologists and geriatricians from rural, urban, academic and community practices in 19 states.
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In interviews with Reuters, seven doctors treating patients for Alzheimer’s attributed their own reluctance to prescribe Leqembi to concerns about the drug’s efficacy, cost and risks.
The use of the FDA-approved Alzheimer’s drug, Leqembi, has slowed down as doctor’s skepticism increases, while patients like Lyn Castellano in St. Louis continue to use the drug as it offers a sense of hope for her future. (Joe Castellano/Handout via REUTERS)
“I don’t think it’s a good Alzheimer’s drug. I think that’s the problem,” said Dr. James Burke, a neurologist at the Ohio State University who has been an outspoken critic of Leqembi. “It’s certainly nothing like the home run that we’re looking for.”
Another six scientists, all leaders in the field, said “therapeutic nihilism” – the belief that Alzheimer’s is a hopelessly intractable disease – was playing a bigger role than anticipated in suppressing demand from primary care doctors, geriatricians and neurologists who could be sending patients to memory specialists for treatment.
Dr. Reisa Sperling, a neurologist and Alzheimer’s researcher at Mass General Brigham in Boston, likens some doctors’ skepticism to Leqembi to fatalistic attitudes about cancer treatment 30 years ago: “You can’t really do anything about it, so why would you even want to get tested?”
Alex Scott, Eisai’s chief administrative officer, acknowledged that skepticism has weighed on the launch along with slower-than-expected adoption by large health systems.
He suggested that some of the doctors’ hesitancy could be a holdover from the decades-long journey to prove that removing the Alzheimer’s protein beta amyloid from the brain could slow the course of the disease. Before Esai released the promising results of its Leqembi trial, some thought that area of research “a fool’s errand,” Scott said.
“We are beginning to make more and more progress every single month. So we’re still quite encouraged,” Scott said. “This is a new journey, and I think it takes some time for providers to figure it out.”
‘SIGNIFICANT RISKS, MARGINAL BENEFIT’
Leqembi was the first amyloid-targeting drug granted full FDA approval after it slowed the decline in cognition in people in the early stages of Alzheimer’s by 27% in a clinical trial.
Of the 10,000 Americans the companies hoped to treat by the end of March, Eisai announced only a couple thousand had begun treatment as of the end of January. An Eisai spokeswoman declined to provide updated numbers.
Even for treatments that do not require dramatic changes to medical practice, adoption of new drugs is notoriously slow. Several studies have estimated that it can take 17 years on average for clinical research to be translated into routine practice.
The disease is estimated to affect more than 6 million Americans, according to the Alzheimer’s Association.
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Fewer than half of U.S. neurologists recommend Leqembi to patients, according to a January survey by life sciences market researcher Spherix Global Insights.
Dr. Michael Greicius, a professor at Stanford University’s Center for Memory Disorders, said there is little evidence that Leqembi benefits patients in a meaningful way.
“If we take the trial result at face value, the differences between placebo and treatment are likely small enough as to be undetectable by patients and family members or physicians,” said Greicius, who does not recommend Leqembi to patients.
He said the long wait for an Alzheimer’s drug has put doctors in the position of feeling obligated to offer a treatment “even if the evidence for it is very slim.”
Other doctors have raised concerns about the risk of brain swelling and bleeding associated with Leqembi as well as the costs associated with the $26,500 annual drug, frequent MRIs and twice-monthly infusions.
“There are significant risks associated with these drugs, there are significant costs, and I would say there is marginal benefit,” said Dr. Eric Widera, a geriatrician and professor at University of California San Francisco, referring to amyloid-lowering treatments.
In an editorial published in November in the Journal of Gerontological Nursing, Donna Fick, president of the American Geriatrics Society, advised doctors that the group recommends caution in the use of lecanemab, which is sold under the brand name of Leqembi.
“It is not yet clear whether treatments such as lecanemab that remove amyloid from the brain produce clinically important slowing of cognitive decline in Alzheimer’s disease.”
‘YOUR ENEMY IS NIHILISM’
Dr. Jonathan Liss, a neurologist from Columbus, Georgia, who serves on Eisai’s scientific advisory board and has tested Leqembi in clinical trials, said he first warned about nihilism at a November 2022 conference following a presentation of Leqembi’s breakthrough study.
Eisai had asked its scientific advisors how the drug might fare against future rivals. Liss cautioned that rivals were not the enemy; “your enemy is nihilism,’” he recalled. “All of the neurologists around the table started applauding.”
FIRST DRUG PROVEN TO SLOW ALZHEIMER’S WON’T BE AVAILABLE TO MOST PATIENTS FOR SEVERAL MONTHS
Dr. Nathaniel Chin, a geriatrician with the University of Wisconsin’s Alzheimer’s Disease Research Center, said he was the target of negative comments on social media after he urged geriatricians to embrace such treatments in the Journal of the American Geriatrics Society.
Geriatricians, geriatric social workers and nurses objected, arguing that the drug’s statistically significant benefit was not clinically meaningful to patients, especially given the risks, he said.
“I would ask the question, ‘Is it ethical to withhold a medication that is FDA-approved and covered by insurance from someone who knows the risk and is willing to take it?’” Chin said.
Dr. Priya Singhal, executive vice president and head of development at Biogen, acknowledged some apathy among physicians about the treatment but said that infrastructure and lack of access to neurologists have been bigger issues.
Singhal said the companies are working with physician and patient advocacy groups and developing educational programs and materials aimed at diagnosing early-stage patients, managing side effects and understanding the drug’s benefits.
The companies said they intend to increase their salesforce by 30% as they aim for 100,000 patients by 2026.
For the moment, Leqembi is the only Alzheimer’s drug on the market designed to slow the course of the disease. A decision on Lilly’s donanemab has been delayed until the FDA convenes an advisory panel.
Lilly neuroscience president Anne White said in an interview that she sees doctor hesitancy as an issue that the company hopes to address by making clear which patients benefit from such treatments.
In the early stages of Alzheimer’s, many patients are still independent, and to be able to remain so for longer is very meaningful, she said.
‘PEACE AND QUIET’
Lyn Castellano, 64, who founded and ran a St. Louis breast cancer charity for 20 years and trained therapy dogs, started taking Leqembi last September, nearly a year after she found herself struggling with keeping track of appointments and was diagnosed with mild cognitive impairment.
Castellano said the prospect of bleeding in the brain – a possible side effect of the drug – was her biggest concern, but her family believed the drug may offer a chance at slowing the disease.
She is one of more than 140 patients being treated by physicians from Washington University in St. Louis, and has had 13 infusions and two MRIs without incident.
Dr. Suzanne Schindler, an Alzheimer’s researcher who is treating Castellano, said Leqembi “forces clinicians to completely change the way they have practiced medicine for many years.”
She said she is candid about Leqembi’s modest benefit as well as the risks. About 80% of those she believes are good candidates have opted for the treatment, she said.
While Castellano can’t tell if Leqembi is helping, she says the treatment has given her hope, and she doesn’t mind the twice monthly infusions.
“I get to go, sit back in a nice chair, have my dog with me and read a book for a couple hours. It’s about the only place I get some peace and quiet.”
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Fireworks have been a quintessential part of Fourth of July celebrations across the nation for generations.
But as Independence Day festivities light up the night sky, the colorful displays can also pose serious health risks — especially to the lungs.
Nearly 300 million pounds of fireworks are released into the atmosphere each year in the U.S., according to the American Lung Association. This creates smoke filled with tiny particles, as well as gases like sulfur dioxide, carbon dioxide and carbon monoxide, which are “very harmful to our lungs.”
QUITTING SMOKING COULD OFFER A MAJOR BENEFIT BEYOND HEART AND LUNG HEALTH, STUDY FINDS
The smoke from fireworks can also release harmful metals, like aluminum, manganese and cadmium, into the air.
Some illegal fireworks may contain lead, which the association describes as “extremely dangerous” due to its potential to cause lasting health damage.
Attendees watch the Independence Day fireworks display along the National Mall in Washington, D.C. (Probal Rashid/LightRocket via Getty Images)
“Inhaling any of these chemicals can irritate the lungs, making it hard to breathe and causing serious health problems, which is why it is important to avoid firework smoke whenever possible,” the group said in a public advisory.
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Air pollution levels increase by an average of 42% on the Fourth of July, according to a 2015 study.
Smoke from fireworks can worsen symptoms and cause flare-ups in those who have asthma or chronic obstructive pulmonary disease (COPD).
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Fine particle pollution has also been linked to more serious health consequences, including heart attacks, stroke, lung cancer and premature death, according to the American Lung Association.
The organization warned that children, older adults and pregnant women, as well as people with lung and heart disease, are especially vulnerable.
Smoke from fireworks can worsen symptoms and cause flare-ups in those who have asthma or chronic obstructive pulmonary disease. (iStock)
Dr. Afif El-Hasan, member of the Lung Association’s board of directors, shared some advice for high-risk fireworks spectators in an interview with Fox News Digital.
Instead of using fireworks at home, El-Hasan recommends watching them from a distance.
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People with asthma who use a rescue inhaler should keep it close at hand in case fireworks trigger wheezing or other symptoms, the expert advised. Wearing a well-fitting N95 mask can also help reduce exposure to fine particles from fireworks smoke and debris.
“If you are familiar with the area and the wind patterns, try to be upwind from the fireworks display and avoid areas where smoke may accumulate,” he said.
An expert recommends watching fireworks from a distance to avoid exposure to air pollution. (iStock)
The expert also recommends attending fireworks events with friends or family, so someone is available to help if a medical emergency arises.
“Make sure you have taken all of your preventative medication before a fireworks show,” El-Hasan advised. “If possible, take a car to the fireworks display. Try to park as close as possible to the event in case you have to get to the car quickly.”
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The expert also recommends drinking water immediately after the show to clear the upper airway. Changing and washing clothes upon returning home can also help to prevent smoke particles from accumulating in the home.
If case of shortness of breath or chest pain, it’s important to seek medical care immediately.
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A study of World Trade Center responders found that PTSD is associated with molecular changes linked to accelerated biological aging and a higher risk of chronic disease.
The study, led by Stony Brook University in New York, could offer new clues to the long-term physical health effects of post-traumatic stress disorder.
The researchers tested blood samples from 393 WTC responders, collected approximately 18 years after the September 11, 2001, attacks, according to a university press release.
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Out of the sampled responders, 232 were diagnosed with PTSD and 161 were not. Between the two groups, 114 proteins and seven metabolites were significantly different.
Firefighter Gerard McGibbon, of Engine 283 in Brownsville, Brooklyn, prays after the World Trade Center buildings collapsed on September 11, 2001. (Mario Tama/Getty Images)
In particular, the researchers detected changes in blood markers linked to brain function, immune activity, energy metabolism, protection against cell damage and how cells communicate and repair tissues.
Also reported were signs of accelerated biological aging in multiple organs — including the heart, kidneys, liver and lungs — among responders with PTSD.
COMMON VITAMIN MAY INFLUENCE BRAIN AGING IN WAYS SCIENTISTS DIDN’T EXPECT
These discoveries could help explain why people with long-term PTSD are at greater risk for chronic conditions such as heart disease, lung disease, cognitive decline and other age-related illnesses.
“This study found that chronic PTSD is associated with long-lasting biological changes throughout the body, affecting multiple organs and biological systems decades after their traumatic exposure,” lead study author Benjamin Luft, director and principal investigator at the Stony Brook WTC Wellness Program, told Fox News Digital.
“Traumatic experiences can produce lasting biological changes that persist for decades.”
The study reinforces the view that PTSD is a “whole-body illness” rather than simply a mental health disorder, he noted.
“Traumatic experiences can produce lasting biological changes that persist for decades,” Luft said. “These changes appear to accelerate aspects of biological aging and may increase the risk of many chronic diseases.”
FOX NEWS’ ERIC SHAWN REVEALS CANCER AND RESPIRATORY ILLNESS FROM 9/11 TOXIC DUST
Several proteins that are critical for healthy brain function were also altered in those with PTSD, the researchers found.
“Many of these proteins play critical roles in helping brain cells communicate with one another, repair damage and maintain healthy connections that support memory and thinking,” Luft said.
A New York firefighter is pictured amid the rubble of the World Trade Center following the 9/11 attacks in 2001. (Universal History Archive/Universal Images Group via Getty Images)
The study – which was funded in part by the CDC, the National Institute for Occupational Safety and the National Institutes of Health – was published in Nature Communications.
Luft said the findings should be viewed with “cautious optimism.”
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“The research provides compelling evidence that PTSD is associated with long-lasting biological changes throughout the body, including signs of accelerated aging, altered metabolism and changes in proteins involved in brain health,” he said.
“These findings strengthen the growing recognition that PTSD is not simply a mental health disorder, but a condition that can have lasting effects on physical health as well.”
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Dr. Marc Siegel, Fox News senior medical analyst, was not involved in the study but called the results “fascinating.”
“This speaks to the complex reality that PTSD is not an isolated psychiatric event due to emotional trauma alone, but that it is also tied in with physical trauma,” he told Fox News Digital. “The stress is both emotional and physical, and leads directly to immune dysregulation and aging processes.”
“These findings strengthen the growing recognition that PTSD is not simply a mental health disorder, but a condition that can have lasting effects on physical health as well,” the researcher said. (iStock)
“The chronic diseases that resulted from high exposure in the aftermath of the 9/11 World Trade Center attacks were conjoined in terms of the impact on physical and emotional well-being, longevity and effects on multiple organ systems, as well as core metabolic and immunological processes,” the doctor added.
Study limitations
There were some limitations to the findings, the researchers noted.
“Because all measurements were taken at one point in time, the research can only show an association — not that PTSD directly caused the changes,” Luft noted.
“We are currently doing studies in these patients examining multiple time points to see whether the changes in specific proteins and metabolites precede clinical changes.”
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Also, because the study was done on a unique population – World Trade Center responders who experienced very specific trauma and environmental exposures – the findings may not apply to everyone with PTSD, “such as combat veterans, survivors of abuse or people who experienced other types of trauma.”
Several proteins that are critical for healthy brain function were also altered in those with PTSD, the researchers found. (iStock)
Women are not well-represented in the study, comprising only 10% of responders.
“Blood tests cannot tell us exactly what is happening inside the brain,” Luft said. “Although many of the altered proteins are related to brain function, blood measurements are only an indirect reflection of processes occurring in the brain.”
Looking ahead
Additional studies are needed to determine whether these blood markers can predict disease progression or treatment response.
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“From a public health and policy perspective, the study reinforces the importance of recognizing PTSD as a chronic medical condition with significant long-term health implications,” Luft said.
“Investing in early diagnosis, comprehensive treatment and long-term follow-up for trauma survivors, including our first responders and veterans, may improve quality of life while reducing the burden of chronic disease.”
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